What You Need to Know: Med Device UDI Submission to China

The National Medical Products Administration (NMPA) is the regulating body in China for drugs and medical devices. Specifically, for medical devices, the NMPA has departments dealing with medical device registration (pre-market approvals) and supervision (post-market requirements). The NMPA has responsibilities including drafting laws and regulations for drugs, medical devices and cosmetics, as well as establishing medical device standards and classification systems. NMPA has implemented an electronic medical device registration management system and has identified Unique Device Identifier (UDI) requirements. Although the regulatory process can be challenging due to rapid change, bringing medical devices to market in China is a high-potential future growth area for many US manufacturers.

To prepare the world market for regulatory compliance in China, NMPA has published guidance on medical device UDI and require registration and UDI data submission for specific product classes. An UDI pilot began in 2019 and has continued to the present. The first group of products (Group 1, consisting of 64 categories of high-risk implantable devices) are planned for required UDI data submission 2020 October.

If companies are looking towards future market growth in China, a number of details will need careful monitoring to reach that goal.

This webinar will give an introductory presentation on NMPA current status, what we have learned via testing and a Q&A session. Bring your specific questions concerning medical device registration scenarios, China NMPA data elements and requirements. The speakers will review and provide clarity on currently posted guidance and answer your questions on the differences between FDA GUDID and China NMPA.

Speakers

Gary Saner, Sr. Manager, Information Solutions Life Sciences, Reed Tech

Gary Saner is a subject matter expert on medical device unique identification and other structured content reporting to regulatory agencies and commercial organizations. He has over 30 years of experience in the areas of software development, process management and data administration with the last 15 years, focused on the life sciences industry. With an understating of regulations, business requirements, and systems, he has helped shape and implement solutions at Reed Tech for data management, validation and processing of drug labeling and medical device unique device identification content. He serves as co-chair of the industry’s Structured Product Labeling Technical Team and on the Advisory Board of the Medical Devices Group.

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John Lorenc, Senior Manager Regulatory Solutions, Reed Tech

John Lorenc directs electronic submission and regulatory requirement initiatives that impact both the medical device and pharmaceutical industries. He has advanced experience with electronic drug product labeling and listing requirements, and global Unique Device Identification (UDI) submissions. He participated as an industry resource in the original FDA pilot in 2012 and is currently focused on the present-day requirements for EU UDI and South Korea and China. He represents Reed Tech in membership with MedTech Europe.

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